🔍 Summary (Quick Insights) Introduction A robust NDSRI Risk Assessment Methodology is now a core element of modern pharmaceutical impurity […]
Deep Dive: Risk Assessment for Nitrosamine Drug Substance-Related Impurities (NDSRIs) Read More »
Introduction: Bioanalytical method validation is the foundation of credible pharmacokinetic, toxicokinetic, and bioequivalence data submitted to regulatory agencies. In simple
Essential FDA Guidelines for Bioanalytical Method Validation Read More »
Summary (Quick Insights) Introduction When multiple nitrosamines are detected in a single drug product, defining the Acceptable Intake for Multiple
Strategies for Managing Multiple Nitrosamines in a Single Drug Product (Total AI) Read More »
Summary (Key Takeaways) Introduction: Defining Nitrosamine Specification Setting in the Pharmaceutical Context Nitrosamine Specification Setting refers to the systematic process
Establishing Specifications for Nitrosamines in Drug Substances and Drug Products Read More »
Introduction Small molecule bioanalysis remains one of the most critical disciplines in pharmaceutical research and development, serving as the foundation
Small Molecule vs. Large Molecule Bioanalysis: Key Differences Read More »
Introduction: The Nexus Between Nitrosamine AI Limit and CPCA Category The connection between the Nitrosamine AI limit and CPCA category
The Role of Acceptable Intake (AI) Limit Derivation and CPCA Category Assignment Read More »
Introduction Less-Than-Lifetime (LTL) Exposure Calculations for Nitrosamines are a critical toxicological tool used when patient exposure to nitrosamine impurities occurs
Less-Than-Lifetime (LTL) Exposure Calculations for Nitrosamines: When and How to Apply Read More »
Introduction: Why Bioanalysis in Drug Development Is Critical Today Bioanalysis in drug development plays a foundational role in translating a
The Role of Bioanalysis in Modern Drug Development Read More »
🔹 Executive Summary Introduction: Understanding the Nitrosamine AI Limits Comparison When conducting a Nitrosamine AI limits Comparison across major regulatory
Global Regulatory Divergence: FDA vs. EMA vs. Health Canada on AI Limits Read More »
Introduction: Understanding the Impact of ICH M7(R2) Updates on Nitrosamine Risk Assessment The Impact of ICH M7(R2) Updates on Nitrosamine
The Impact of ICH M7(R2) Updates on Nitrosamine Risk Assessment and Control Read More »
